15 Oct, 2024 CBO Pours Cold Water on Retail Pricing Impact of Legislation to Expedite Generic Drug and Biosimilar Entry By Jim Czaban The Congressional Budget Office (CBO) has just released a report that seems to cast shade on recent legislative proposals that aim to...
12 Sep, 2024 FDA Serves Up a Stricter Enforcement Standard for Celebrities Endorsing Rx Drugs By Jim Czaban Being a celebrity has its challenges. Adding a new one to the list, the U.S. Food and Drug Administration (FDA) has recently issued an...
21 Aug, 2024 Allergan Holding Protects "First-Filed" Parent Patents from Their Misbehaving Patent Offspring By Jonathan B. Thielbar This month, in Allergan USA, Inc. v. MSN Laboratories Private Ltd., the Federal Circuit added to the ongoing patent-family drama...
14 May, 2024 GSK Joins COVID-19 mRNA Vaccine Patent War By Dan Liu mRNA-Based Vaccine and Other Therapeutics mRNA-based vaccines have become one of the most discussed technologies both inside and outside...
25 Apr, 2024 Amending ANDA by Purportedly Carving Out Infringing Use—After Trial—Does Not Rescue the Amended ANDA from the Negative PIV Judgment By Dan Liu The district court in Salix Pharmaceuticals, Ltd. et al v. Norwich Pharmaceuticals, Inc., Civil Action No. 20-430-RGA (D. Del.) was asked...
13 Mar, 2024 Are FDA Astronauts Coming Soon? Implications of the Revolution in Space-Based Drug Manufacturing By Jim Czaban Recent news reports have described the successful progress of at least one company, Varda Space Industries, in developing a space-based...
31 Jan, 2024 Lessons Learned: FDA Digs Up, and Discards, Time-Capsule Citizen Petition Re: Online Drug and Device Promotion By Jim Czaban The FDA Citizen Petition ("CP") process is a widely used, but often seemingly fruitless tool by which interested persons and entities can...
04 Dec, 2023 The Perils of Incorporation by Reference at the Federal Circuit By Ryan Hagglund Because judicial resources are limited, virtually all courts impose length limitations, such as word, page, or line limits, for briefing....
15 Nov, 2023 FDA's First Interchangeable Biosimilar Exclusivity Decision -- Prelude to a New Wave of FDA Litigation? By Jim Czaban FDA has released an 18-page internal decision memo which for the first time lays out the agency's interpretation of how regulatory...
14 Nov, 2023 Demand for Weight Loss Drugs: Pounds Drop, but Counterfeit-Related Hospitalizations Rise By Kristen R. Klesh Melanie J. Howard Admittedly, the topic of weight loss isn't the ideal “Turkey-Day” conversation starter. Nevertheless, when the discussion relates to a...
13 Nov, 2023 Federal Circuit Requires Analysis of Extrinsic Evidence in Construction of "a pH of 13" By Ryan Hagglund Earlier this week, in Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc., No. 22-1889, 2023 U.S. App. LEXIS 29433 (Fed. Cir....
08 Nov, 2023 FTC's New Orange Book Listing Complaints Target Drug Delivery Device Patent Issue That FDA Has Ignored For Years By Jim Czaban The Federal Trade Commission (FTC) is at it again, jumping into the Food and Drug Administration's sandbox with a splashy press release...